New radiation combo aims to tame prostate cancer with fewer side effects
NCT ID NCT01596816
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to give radiation to men with intermediate-risk prostate cancer. After standard radiation to the prostate and nearby glands, a precise, high-dose boost was added to the tumor. The goal was to improve cancer control while keeping side effects on the bladder and rectum low. 76 men took part, and researchers tracked their urinary and rectal function over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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76 people
The number who actually took part.
- Started
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Aug 2010
- Finished
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Sep 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Prostate adenocarcinoma proved by histology * With at least one of this intermediate-risk criterias: * T2b * and/or PSA between 10 et 20 ng/ml * and/or Gleason score = 7 * Prostatic volume ≤ 80 cc * No adenopathy(lymph node \< 1.5 cm on scanner or MRI and/or in lymph node dissection) * No metastasis (bone scan) * Age \>= 18 ans * No prior pelvic irradiation * No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy \> 3 months) * Performance status (ECOG) \< 1 * No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation * Life expectancy \>= 10 weeks * Patient affiliated to health insurance * Informed consent signed by the patient Exclusion Criteria: * Cancer no histologically proved * Unfavorable-risk(T2c and/or PSA \> 20 ng/ml and/or Gleason \> 7) * Favorable-risk(T1c T2a and PSA \< 10 ng/ml and Gleason \< 7) * T3 and T4 * History of cancer uncontrolled and/or treated since less of 5 years (except basal cell carcinoma of the skin) * Contraindication to MRI * IPSS score \> 10 * Recurrent or metastatic disease * Allergy to gold * Patient already included in another therapeutic trial with an experimental molecule * Unable for medical follow-up (geographic, social or mental reasons)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
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Centre Georges François Leclerc
Dijon, 21079, France
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Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
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Centre Léon Bérard
Lyon, 69373, France
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Centre Oscar LAMBRET
Lille, 59020, France
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Centre Paul Papin
Angers, 49933, France
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Val d'Aurelle-Paul Lamarque
Montpellier, 34298, France
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